Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification

On Oct. 13, the U.S. Food and Drug Administration issued new guidance on molecular diagnostic tests for influenza and respiratory syncytial virus (RSV). The upshot of the guidance is to temporarily allow makers of flu and RSV tests that the agency has already cleared to make certain modifications to those products without submitting 510(k) premarket notification in the interests of making the tests more widely available while also not using up reagents needed for SARS-CoV-2 testing. There is significant overlap in warning signs and symptoms between SARS-CoV-2 and other respiratory viral infections, including influenza and RSV, the guidance explains. “Increased availability of molecular influenza tests during the COVID-19 pandemic is important due to the similarity in symptoms between COVID-19 and the seasonal influenza.” The guidance also notes that because of this overlap in symptoms, molecular influenza tests are often offered as part of a panel of tests including RSV. Diagnostic tests for SARS-CoV-2 and other respiratory viral infections generally use many of the same components. For example, the same specimen collection devices and transport media required to perform many FDA-cleared molecular influenza tests are also needed for most molecular diagnostic SARS-CoV-2 assays. And, of course, those devices and media are […]